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510(k) K901928

INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH by Interpore Intl. — Product Code EGG

K901928 is an FDA 510(k) premarket notification submitted by Interpore Intl. for the device "INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH". The FDA issued a decision of Substantially Equivalent on July 26, 1990. The device falls under product code EGG (Attachment, Precision, All), a Class I device regulated under 21 CFR 872.3165. Interpore Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1990
Date Received
April 27, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Attachment, Precision, All
Device Class
Class I
Regulation Number
872.3165
Review Panel
DE
Submission Type

Other clearances by Interpore Intl.

  • K981253 — ULTRACON ULTRAFILTRATOR (December 11, 1998)
  • K980817 — PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05, 5R (September 25, 1998)
  • K972842 — INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE (October 30, 1997)
  • K971036 — ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (June 3, 1997)
  • K960945 — IMZ MEMBRANE TACK SYSTEM (May 24, 1996)
  • K960371 — INTERPORE THREADED IMPLANT (March 8, 1996)
  • K955492 — INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT (January 30, 1996)
  • K952167 — IMZ BONE TACK SYSTEM (November 21, 1995)
  • K950165 — INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 100 (March 28, 1995)
  • K922872 — INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM. (July 25, 1994)

Other clearances for product code EGG

  • K990979 — STECO-TITANMAGNETICS (September 3, 1999)
  • K950259 — COUPLING DEVICE FOR DENTAL PROSTHESIS (December 6, 1996)
  • K925700 — ZEST ANCHOR ADVANCED GENERATION (April 7, 1994)
  • K915299 — COGAN CORP KITS OF DENTAL HAND INSTRUMENTS (January 31, 1992)
  • K912435 — DENTAL CONNECTOR PRECISION ATTACHMENT (August 28, 1991)
  • K912567 — CONICAST, INTRACAST, OMECAST (July 2, 1991)
  • K900785 — MICRO 2 SYSTEM (April 16, 1990)
  • K896337 — DENTAL BRIDGE ANCHORING PINS (January 31, 1990)
  • K895986 — PRECISION DENTAL ATTACHMENTS (October 18, 1989)
  • K891119 — T.R.S.: TOOTH REPLACEMENT SYSTEM (April 17, 1989)

FDA data resources